Clinical trial · Interventional
Clinical Study on Neoadjuvant Therapy of Homoharringtonine Combined With Androgen Deprivation for Prostate Cancer
A Randomized Controlled Study of Homoharringtonine Combined With Androgen Deprivation in Neoadjuvant Therapy for Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The high incidence of prostate cancer is one of the important diseases that threaten the health of old men in our country. Although androgen deprivation therapy is an important treatment option for prostate cancer, although neoadjuvant androgen deprivation therapy combined with radical prostatectomy reduced the positive rate of surgical margins, it did not show statistically significant improvement in prostate-specific antigen (PSA). At the same time, few trials reported pathological complete response (pCR) and minimal residual lesion (MRD). The purpose of this project is to verify the therapeutic effect of homoharringtonine combined androgen deprivation in patients with locally advanced prostate cancer or oligometastatic prostate cancer before radical prostatectomy through a randomized controlled clinical trial, so as to find an effective treatment for locally advanced prostate cancer or oligometastatic prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate CA | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Homoharringtonine combined with androgen deprivation therapy | Drug | — | UNRESOLVED |
| Placebo combined with androgen deprivation treatment group | Drug | — | UNRESOLVED |
| radical prostatectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Homoharringtonine combined with androgen deprivation treatment group
- description
- Homoharringtonine 1mg intravenous infusion +5% glucose injection 250ml intravenous infusion, once a day for two consecutive days, repeated administration after three weeks of intermittent treatment, lasting two cycles + continuous androgen deprivation therapy，radical prostatectomy was performed 3 weeks later (±7 days).
- interventionNames
- Drug: Homoharringtonine combined with androgen deprivation therapy
- Procedure: radical prostatectomy
- type
- PLACEBO_COMPARATOR
- label
- Placebo combined with androgen deprivation treatment group
- description
- Placebo 1mg intravenous infusion +5% glucose injection 250ml intravenous infusion, once a day for two consecutive days, and repeated administration after a break of three weeks for two cycles + continuous androgen deprivation therapy，radical prostatectomy was performed 3 weeks later (±7 days).
- interventionNames
- Drug: Placebo combined with androgen deprivation treatment group
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria:
* ① Age ≥18 years and ≤85 years;
* Histologically confirmed prostate cancer without small cell features;
* Metastatic prostate cancer was identified by imaging examination with ≤5 oligometastases (bone or lymph node metastases) or cT3-4 stages; ④The score of ECOG (Eastern Cooperative Oncology Group) was 0-1; ⑤ All patients voluntarily sign informed consent, and can adhere to treatment and follow-up;
Exclusion Criteria:
* ①Any previous or ongoing PCa treatment, including radiotherapy, chemotherapy, ADT, etc.
* Previous prostatectomy;
* Any other serious basic medical, mental, psychological, and other diseases that, in the judgment of the investigator, may affect the treatment of the patient
* Allergic to the drugs used; ⑤ Refuse to undergo radical prostatectomy; ⑥ According to the investigator's judgment, it is not suitable to participate in this clinical trial;References
Publications (1)
- DERIVEDCheng Y, Wan L, Huang E, Zheng B, Ding X, Tan S, Ma G, Li W, Chu C, Wu T, Chen S, Zhuang J, Na R, Chen Z, Teng G, Zhang D, Ju S, Chen M, Xu B. A conserved eIF1A+ luminal cell-centered hypoxic and "cold" tumor microenvironment promotes pan-subtype prostate cancer progression. Cell Rep Med. 2026 Feb 17;7(2):102619. doi: 10.1016/j.xcrm.2026.102619. PMID 41707646